Manufacturing Validation Engineer
Job in
Lawrence, Essex County, Massachusetts, 01840, USA
Listed on 2026-11-01
Listing for:
United Pharma
Full Time
position Listed on 2026-11-01
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Pharma Engineer, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
The scope of work may involve the following activities:
1. Support the validation activities involved with landing and commissioning new manufacturing equipment
2. Review and Approve IQ, OQ, PQ, TMV or Software Validation deliverables.
Activities to be performed:All Validation activities with respect to Vendor Selection, Feasibility trials, Development Work, Vendor Testing, Equipment Installation, Commissioning, Mold Qualification, Software Validation, Process Validation, Stability in Client's Site.
- Interacting with Vendor, EHS, Quality, Validation and other various cross functional departments.
- Drafting and Review of validation documents.
- Preparation of validation documents CAF, IQP, IQ report, OQP, OQ report, PV / PQ protocols & reports, Engineering trials, etc.
- Creation/Updates of URS, SWS, TM, WI, WRAPS, JSA, pFMCA, CSOP, MCP etc.
- Execution of validation documents CAF, IQ, OQ, PV, PQ, Engineering Trials.
- Release in PLM Windchill
- Creation of CR / CN documents.
- Review the documents with onsite team member and cross functional departments.
- Follow up the approvers.
- Release the documents in PLM Windchill
- Education:
Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline. - Experience:
6+years in manufacturing and equipment validation in a regulated environment (Med Tech, pharma, or healthcare devices). - Regulatory & Standards:
Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ). - Technical
Skills: - Proficiency in developing and executing IQ/OQ/PQ protocols.
- Experience with metrology, calibration, and measurement system analysis.
- Knowledge of foundry casting process.
- Statistical tools experience (Minitab, JMP, or similar) for process capability studies.
- Document control and eQMS systems experience (e.g., Master Control, ETQ, etc.).
- Communication:
Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.
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